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maxwell_active

Maxwell Shane

@maxwell_active

Creative Lead, Compliance Consultant team for food, cosmetic, medical device

États-Unis
Anglais, Français, Allemand
Certaines informations sont présentées en anglais.
À propos de moi
Hello and Welcome. I’m Maxwell Shane, an FDA Regulatory Compliance Consultant with 68+ registrations and compliance projects completed and 43+ one-on-one consultations delivered. I help food, supplement, cosmetic, medical device, and import businesses with FDA registrations, product listings, U.S. Agent support, Prior Notice, MoCRA compliance, and FSMA documentation. My approach is to help identify the correct regulatory pathway, prepare accurate documentation, and help clients avoid delays and costly mistakes. I'm very accessible and competent. KINDLY SEND A DM NOW TO GET STARTED WITH US!... Plus d’infos

Compétences

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maxwell_active
Maxwell Shane
hors ligne • 
Temps de réponse moyen de 1 heure

Voir mes services

Immatriculation d'entreprise
I will complete fda food facility registration, fsma compliance and US agent support
Immatriculation d'entreprise
I will prepare fda 510k estar submission documentation for medical devices, fsvp

Expérience professionnelle

Moirar_Holistic Wellness

Import Compliance Coordinator

Moirar Holistic Wellness • Freelance

Jul 2026 - Present • 3 mos

- Prepared Prior Notice submissions for incoming food shipments and verified details against commercial documents before arrival. - Coordinated with exporters, brokers, and importers to fix missing or inconsistent information that could cause shipment holds. - Maintained organized compliance records for dietary supplement, cosmetic, and medical device clients, ready for review at any time. - Tracked renewal and update deadlines across multiple facilities so registrations stayed active and accurate.

Maxwell_Leadership

FDA Regulatory Compliance Consultant (Independent)

Maxwell Leadership

Jul 2025 - Present • 1 yr 3 mos

- Managed FDA registration renewals and updates for Max Lea facilities, keeping records accurate and on schedule. - Supported import operations by preparing Prior Notice information and checking shipment documentation against FDA requirements. - Helped build FSMA-aligned documentation, including [food safety plans / supplier records / procedures]. - Served as the main contact between the business and regulatory requirements, translating rules into practical action steps.

Zentz_Marketing

Regulatory Compliance Specialist

Zentz Marketing • Temps plein

Apr 2025 - Jun 2026 • 1 yr 2 mos

- Prepared and submitted FDA Food Facility and MoCRA cosmetic facility registrations, including product listings, with zero rejections due to data errors. - Reviewed manufacturer information, product categories, and supporting documents before submission to prevent delays and costly corrections. - Provided U.S. Agent support for [number] foreign facilities, serving as the point of contact for FDA communications. - Advised clients one-on-one on the correct regulatory pathway and gave written compliance recommendations.